ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation

Not Applicable

Completed

• Conditions: Tracheal Intubation
• Interventions: Device: i-gel; Device: ILMA

• Registration Number: NCT00888875
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.

Detailed Description

The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway device that is inserted blindly. It may be used to facilitate intubation and secure the airway in routine practice, in difficult airway scenarios or in emergency situations. Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the success rate. The i-gel™ is a newly developed supraglottic airway device and is also introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided.

So far, prospective randomized controlled trials comparing their performance are not yet published. There are case reports about intubating over the i-gel.

In this prospective, randomized, controlled trial, we are going to evaluate the performance of intubation through both devices. In 250 patients undergoing elective surgery, we will place either the ILMA or the i-gel according to randomization and then intubate with the help of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA stabilizer rod.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-28
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• elective operation with intubation
• ASA I-IV
• speaks German
• at least one predictor for difficult intubation

Exclusion Criteria

• weight <30kg
• Risk Aspiration
• Risk bleeding orally
• known or highly suspected difficult mask ventilation
• Mouth opening < 20mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	i-gel	Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube
2	ILMA	Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube

Primary Outcome Measures

Name	Time	Method
successful intubation attempt with ventilation of both lungs	during intervention

Secondary Outcome Measures

Name	Time	Method
insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects	during intervention and first 24hours after operation
simulated blind intubation in both groups	during intervention

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Berne, Switzerland